The Rhode Island Department of Health has adopted new regulations for the licensure of Canadian pharmacies that are substantially tougher than those approved in December, with restrictions on which drugs can be imported and mandatory compliance with all the U.S. Food and Drug Administration’s requirements.
Pharmaceutical industry leaders had been urging health officials to take that approach, saying local consumers would be otherwise be in danger. But while the industry had hoped the state would also abide by the FDA’s ban on importation – and just provide for licensure if the ban is lifted – Health spokesman Robert J. Marshall said that rule is excepted.
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In January, after the state adopted regulations that treated Canadian pharmacies basically the same as their counterparts in other U.S. states, the FDA wrote to Atty. Gen. Patrick C. Lynch urging him to stop Rhode Island from treading into dangerous territory.
“In our experience, many drugs obtained from foreign sources that purport and appear to be the same as U.S. approved prescription drugs have been of unknown origin and quality,” FDA associate commissioner William K. Hubbard wrote. “We cannot provide adequate assurance to the American public that the drug products delivered to consumers in the United States from foreign countries are the same products approved by FDA.”
Lynch conveyed the FDA’s concerns to the Health Department and urged officials to pass stricter and more detailed regulations. By then, two Canadian pharmacies had already applied for licenses to sell drugs to Rhode Islanders; two more have since applied.
Health officials put the applications on hold, drafted a new set of proposed regulations, and held a public hearing on June 15. On July 1, after a two-week wait for additional comment, the regulations were submitted to the secretary of state’s office. They go into effect July 21.
The new rules limit shipments from Canada to drugs that have been approved by the FDA, with labels in English, and forbid importation of controlled substances such as narcotics; biological products; infused drugs; drugs that are injected intravenously or inhaled during surgery; drugs manufactured through biotechnology, or items that need to be refrigerated.
In addition, Canadian pharmacies must provide written documentation that they are “in compliance with all FDA and other applicable federal laws and regulations,” as well as a certificate of insurance for $5 million. They must provide patient counseling, as needed, and they must comply with Rhode Island’s patient confidentiality law. In the event of a dispute, the state’s courts would have exclusive jurisdiction.
The current Canadian applicants will be notified of the changes, health officials said. The updated rules are posted at www.health.ri.gov (in PDF form).
